Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enrolled, Not Eligible | These participants were consented and enrolled into the study, but did not meet eligibility criteria. Only adverse events meeting serious criteria were collected for this study. A SAE is defined as "any adverse event that meets on or more serious criterion and occurs within 24 hours of the protocol mandated blood draw for research specimens. Those in the "Enrolled, Not Eligible" Arm/Group did not undergo any protocol mandated blood draws and so no adverse events will be reported for this Arm/Group. | 1 | None | 0 | 0 | 0 | 0 | View |
| Accrued | Accrued participations met all eligibility criteria and completed at least one mechanistic sample collection. Only adverse events meeting serious criteria were collected for this study. An SAE is defined as "any adverse event that meets one or more serious criterion and occurs within 24 hours of the protocol mandated blood draw for research specimens". | 1 | None | 0 | 36 | 0 | 0 | View |